Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TENOFOVIR ALFENAMIDE HEMIFUMARATE IN BULK AND SIMULTANEOUS ESTIMATION OF TENOFOVIR ALFENAMIDE AND EMTRICITABINE IN COMBINED TABLET DOSAGE FORM

Parina Dobariya* and Dr. Mrunal Shirsat 

Abstract

A Simple, specific, precise and accurate chromatographic method for estimation of Tenofovir alafenamide fumarate and Emtricitabine in API and tablet dosage form was developed by C18 column having 250 mm length, 4.6 mm internal diameter, 5μ particle size. Peak was observed in mobile phase consist of Buffer (pH 3.5): Methanol (30:70). The flow rate was 1ml/min. The estimation was carried out at 262 nm. The retention time was found of Emtricitabine 3.6 and Tenofovir alfenamide5.3 minute. Linearity was found in range of 20-60mcg/ml for Emtricitabine Linearity was found in range of 2.5-7.5 mcg/ml for Tenofovir alafenamide The method was validated as per ICH guideline Q2R1. All validation parameters were found to be within accepted range specified in ICH guideline Q2R1.

Keywords: Emtricitabine, Tenofovir alfenamide Hemifumarate, RP-HPLC, ICH guideline Q2R1.